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Breathing bag 0.5L ISO with ho

FDA UDI

Class I (US FDA UDI)

by Drägerwerk AG & Co. KGaA

Identity

Trade Name
Breathing bag 0.5L ISO with ho FDA UDI
Generic Name
Breathing circuit bag, reusable FDA UDI
Model / Reference
2165763 FDA UDI

Identifiers

Primary DI / UDI-DI
04048675023500 FDA UDI
FDA Product Code
BTC FDA UDI
GMDN Term
Breathing circuit bag, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.5320 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Drägerwerk AG & Co. KGaA

Sources (1)

  • FDA UDI f37f6c6c-80d2-4b75-8788-00a793342add 34 fields · synced Oct 6, 2026